BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 10301938 · Received July 21, 2020

    Report

    Report Number
    1416980-2020-04105
    Event Type
    Malfunction
    Date Received
    July 21, 2020
    Report Date
    August 24, 2020
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    MEB
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    H4: THE LOT WAS MANUFACTURED FROM JANUARY 07, 2020 - JANUARY 08, 2020. H10: THE ACTUAL DEVICE WAS NOT AVAILABLE; HOWEVER, A PHOTOGRAPH OF THE SAMPLE WAS PROVIDED FOR EVALUATION. FUNCTIONAL FLOW RATE TESTING MUST BE PERFORMED ON THE ACTUAL DEVICE IN ORDER TO VERIFY THE ACCURACY OF THE ALLEGED DEVICE; THOUGH, THIS IS NOT POSSIBLE DUE TO THE LACK OF A PHYSICAL SAMPLE. THEREFORE, THE REPORTED EVENT COULD NOT BE REFUTED; HOWEVER, BASED ON HISTORICAL COMPLAINT ANALYSIS DATA, THE MOST PROBABLE CAUSE OF THE CONDITION WAS DUE TO A USER RELATED ISSUE. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE EVENT OCCURRED ON AN UNKNOWN DAY IN (B)(6) OF 2020. (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 FOLFUSORS SV (SMALL VOLUME) UNDERINFUSED DURING PATIENT INFUSIONS; FURTHER DESCRIBED AS ¿THE DEVICES HAD NOT EMPTIED COMPLETELY WHEN DEVICES WERE REMOVED¿. THE DEVICES WERE FILLED WITH FLUOROURACIL. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768372 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE CORPORATION NA 20A003

    Patients

    Seq Age Sex Outcome Treatment
    1 FLUOROURACIL| FLUOROURACIL